A biotechnology company required vitamin D distribution as an auxiliary medication for a phase 3 MASH and fibrosis clinical study. When the original supplement vendor was unable to support the study’s full global scope, the company engaged ICON’s Accelerated Pharmaceutical Solutions (APS) team to step in on short notice. The APS team swiftly sourced the required vitamin D, developed study-specific labelling compliant with regulatory requirements across all 16 participating countries, and successfully managed distribution to all sites.

The last-minute engagement placed the APS team under significant time pressure to source and supply the vitamin D without impacting the phase 3 study start—an especially critical objective given the fact that any delay on a phase 3 study carries substantial financial impact. With the study spanning 16 countries and 148 sites, successful execution required meticulous coordination, strategic planning, and effective cross-functional communication across project functions and regions. The complexity of navigating various regional regulations posed challenges, requirements demanding a high degree of flexibility and responsiveness from the APS team to adapt to the evolving needs of the study.

The APS team proactively gathered critical information to establish a comprehensive overview of site locations, supply requirements, and timelines. To ensure greater control over the supply chain and enhance flexibility and cost-efficiency, vitamin D procurement and dosing were managed in-house through a centralised European hub. This approach also facilitated streamlined global distribution and regulatory compliance, supporting the continued success of the ongoing study.

The integrated packaging, labelling, and distribution capabilities within APS ensured the production of accurate, country-specific labels containing all required information in the appropriate target languages. Leveraging regulatory expertise, the team anticipated specific country requirements and proactively conducted in-house analyses to support documentation packages for regions with additional restrictions. By managing this process internally, APS successfully minimised risk and created a more agile supply chain.

By utilising ICON’s integrated packaging, labelling, and distribution systems, this ongoing phase 3 study not only avoided costly delays but also benefited from a more responsive and streamlined supply chain for its auxiliary medication. As a result of our successful performance on this study, the biotech sponsor has contracted ICON to supply vitamin D supplements for two additional studies.

Learn more about our suite of Accelerated Pharmaceutical Solutions and how ICON’s experts can optimise labelling, packaging, and distribution processes for your clinical trials.